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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02512744
Other study ID # 3/7/2015 n67
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2016
Est. completion date May 1, 2018

Study information

Verified date August 2018
Source Hospital Virgen de la Salud
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Multicenter randomized trial centered on critically-ill tracheostomized patients, comparing two different decannulation protocols:

1. based on capping trials to decide decannulation,

2. based on the aspiration frequency to decide decannulation time. High-flow conditioned oxygen therapy will be applied to all patients through the tracheal cannula. In patients included in the suctioning frequency based protocol along the study period and in patients included in the capping trial protocol along periods out of capping trials.


Recruitment information / eligibility

Status Completed
Enrollment 330
Est. completion date May 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Critically-ill tracheostomized patients weaned from mechanical ventilation (24 consecutive hours disconnected).

Exclusion Criteria:

- Patients consedered non-decannulable at time of randomization:

1. unconscious patient (motor component of GCS score <6 points).

2. Severe swallowing function (based on drink test).

3. Airway patency problem (based of intolerance of occlusion test).

4. Neuromuscular diseases.

5. Patients with a Sabadell score >2.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Decannulation protocol.
Comparison of two different decannulation protocols: one protocol based on capping trial tolerance to decide when to decannulate vs. protocol based on suctioning frequency of respiratory secretions to decide when to decannulate (criteria: =2 aspirations every 8 h along 24 consecutive hours).
Device:
High flow conditioned oxygen therapy
High flow conditioned oxygen therapy will be applied during all study period through tracheal cannula in the experimental arm (suctioning frequency based protocol) and during periods out of capping trials in the control arm (capping trials based protocol).

Locations

Country Name City State
Spain Hospital Del Mar Barcelona
Spain Hospital Universitario Vall D´Ebron Barcelona
Spain Hospital Universitario de Ciudad Real Ciudad Real
Spain Hospital Universitario Ramon Y Cajal Madrid
Spain Hospital Virgen de La Salud Toledo

Sponsors (1)

Lead Sponsor Collaborator
Hospital Virgen de la Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Decannulation time Time since weaning from mechanical ventilation (24 consecutive hours disconnected) to decannulation Patients will be followed for the duration of hospital stay, an expected average of 3 months
Secondary Decannulation failure Number of patients requiring recannulation during hospital stay / number of patients included in the group X 100 Patients will be followed for the duration of hospital stay, an expected average of 3 months
Secondary Intensive Care Unit Lenght of stay Time since ICU admission to ICU discharge Patients will be followed for the duration of ICU stay, an expected average of 2 months
Secondary Hospital lenght of stay Time since hospital admission to hospital discharge Patients will be followed for the duration of hospital stay, an expected average of 3 months
Secondary ICU mortality ICU mortality in every study group Patients will be followed for the duration of ICU stay, an expected average of 2 months
Secondary Hospital mortality Hospital mortality in every study group Patients will be followed for the duration of hospital stay, an expected average of 3 months
Secondary Respiratory infection Post-randomization pneumonia and tracheobronchitis rate in every study group Patients will be followed for the duration of hospital stay, an expected average of 3 months
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